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Health and Life Sciences

A collection of law firm publications and PLC resources discussing issues relevant to health and life sciences. To view the full suite of PLC Law Department resources across 18 practice areas, simply visit our homepage.

This Note explores selected legal and compliance issues for acquirors to focus on when pursuing an M&A transaction involving a target that is a manufacturer of pharmaceuticals or medical devices. In particular, this Note reviews the preliminary goals of effective due diligence, provides guidance on key areas of the investigation and highlights some of the strategies acquirors can use to mitigate risk in these deals.

This Practice Note addresses requirements for protecting the privacy of personal health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Among other topics, the Note describes which entities and types of health information are covered by the Privacy Rule, and permitted and prohibited uses and disclosures of health information. The Note reflects final regulations (January 2013) addressing HIPAA privacy, including requirements related to genetic information.

This Practice Note discusses some key issues to consider when structuring and negotiating an option to acquire a pharmaceutical company, such as purchase price, duration of the option, events triggering the option, the relevant product's development plan and antitrust and accounting implications.

A discussion of key provisions in M&A agreements in the healthcare industry in private acquisitions and public mergers. This Note includes links to recent deals summarized in What's Market and will be updated quarterly.

This Note provides a comprehensive overview of the US pharmaceutical industry. It includes a discussion of the main sectors and products, the characteristics of the market, and how it is regulated. It also analyzes the industry's risk factors, the types of legal relationships created, general tax and finance issues, mergers and acquisition considerations and typical strategic alliances.

A model certificate of group health plan coverage, which was previously required to be furnished under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by a group health plan (or health insurer) to a covered individual whose coverage under the plan had terminated. This Standard Document is based on a model published by the Department of Labor and has integrated notes with important explanations and drafting tips.

A sample form to be provided by an individual to a covered entity (CE) acknowledging that the individual received the CE's Notice of Privacy Practices, which is required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This form does not address any applicable state law privacy requirements. This Standard Document has integrated notes with important explanations and drafting tips.

This standard clause provides resolutions that covered entities may use to appoint a privacy and security officer, as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This standard clause includes integrated notes with important explanations and drafting tips.

This article examines the background, implementation and practicalities of new transparency rules, also known as "sunshine rules", introduced into Portuguese law in 2013 for the pharmaceutical industry. The sunshine rules ensure that all payments made by pharmaceutical companies to healthcare professionals and others in the healthcare sector, are registered and visible. The article also considers the wider impact of transparency rules in other related sectors, as well as the precedent that was set by the US, with its original sunshine rules for the pharmaceutical sector. This article is part of the Practical Law multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article outlines the current IP landscape for Gulf Co-operation Council (GCC) countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates) and provides details on: patent applications (including the criteria for registration and the types of discoveries or processes that are not patentable); data exclusivity; trade secrets/confidential information; Sharia law considerations and government initiatives. This article is part of the Practical Law multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

The emergence of integrated health information systems, mobile apps and software-based medical devices presents significant opportunities in managing healthcare costs and achieving better outcomes. This article analyses the developing EU and US approaches to health information technology (health IT) and mobile medical applications (MMAs), and the emerging rules and compliance issues for companies developing and marketing these products. This article is part of the multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Search the Country Q&A in the Life Sciences Multi-jurisdictional Guide/Medicinal product regulation and product liability section by question and jurisdiction. Step 1: Check the boxes to select the questions and the jurisdictions for comparison. Step 2: Click the "submit" button. Step 3: Scroll down to view answers and check law stated dates for each jurisdiction.

Search the Country Q&A in the Life Sciences Multi-jurisdictional Guide Pharmaceutical IP and competition law section by question and jurisdiction. Step 1: Check the boxes to select the questions and the jurisdictions for comparison. Step 2: Click the "submit" button. Step 3: Scroll down to view answers and check law stated dates for each jurisdiction.

The table summarises patent protection and data and marketing exclusivity in the jurisdictions covered in the life sciences multi-jurisdictional guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

The development of new chemical compounds (and increasingly of biologics) for the treatment of human medical ailments remains the primary focus of the world's major pharmaceutical companies. However, the immense cost associated with the development of new chemical entities and biologics provides great incentive for pharmaceutical companies to research new uses for existing drugs. Australia is one country which offers incentive in the development of new uses for known drugs by permitting such developments, which are novel and inventive, to be patented. Against this background, this article examines second medical use patents, indication carve-outs, and the recent Australian High Court decision in the leflunomide case. This article is part of the multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article examines the drug patent-approval linkage system in South Korea and its implications. The system prohibits the sale of generic drugs which would infringe the patents of brand-name pharmaceutical companies who have developed the original drugs, by alerting the original patent holders and by withholding marketing approval. This has the object of protecting the rights of the patent holders. The article considers the background to the patent-approval linkage system, including the FTA agreement entered into with the US and the patent dispute resolution system in South Korea. The article also discusses the way in which the patent-approval linkage system is being implemented. In particular, it examines the notice system that has been put in place to alert patent holders that an application for approval of a generic drug based on their patent is being made, and the expected marketing prevention system which will stop these generic drugs from being marketed while in the approval stage. This article is part of the Practical Law multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

The US Court of Appeals for the Second Circuit has issued an important and long-anticipated decision in United States v. Caronia, No. 09-5006-cr. The court held that construing the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations to prohibit pharmaceutical companies from engaging in truthful and non-misleading speech regarding unapproved or off-label uses of Food and Drug Administration (FDA)-approved drugs violates the First Amendment to the US Constitution. This precedent could have a significant impact on FDA regulations and US government enforcement moving forward. This article examines the facts of the Caronia case, the Second Circuit Caronia ruling, the rationale for the Second Circuit Caronia decision and the impact of the Second Circuit Caronia decision. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

On 1 February 2013, the Centers for Medicare and Medicaid Services released its highly anticipated final rule, implementing section 6002 of the Patient Protection and Affordable Care Act, known as the Physician Payment Sunshine Act (Sunshine Act). This article explores the implications of these requirements for international healthcare product manufacturers and their affiliated entities, by examining the Sunshine Act requirements, in particular who must report, what transfers of value must be reported, when non-US entities must report, the reporting requirements for non-US entities and the need to carefully consider the Sunshine Act. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

The patent system in Europe is set to undergo its biggest overhaul since the 1970s, with the introduction of the Unitary Patent and the Unified Patent Court. After more than 40 years of negotiations, and numerous false starts, the building blocks are in place for a patent with multi-jurisdictional European coverage and a new centralised court system. This article examines the current system, the Unitary Patent, the Unified Patent Court and practical points for life sciences businesses to start considering now. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article sets out a summary of the giving of concurrent expert evidence in Australian patent cases. In particular, it examines expert evidence, concurrent evidence, legislative support, advantages and disadvantages of concurrent evidence, recent cases involving concurrent evidence and the use of concurrent evidence in patent cases. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article analyses the recent developments in enforcement of competition law in the South Korean pharmaceutical industry. It reviews the enforcement issues involving unreasonable inducement of customers (rebates), collaborative acts (cartels), resale price maintenance, unfair trade practices in the supply of pharmaceutical products and abuse of patent rights. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

The recent revocation of two pathbreaking pharmaceutical patents in India shows interesting developments in Indian patent law. Against this background, this article examines the revocation of Pfizer's Sunitinib patent and the revocation of Roche's patent for a hepatitis C drug (pegasus). This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article examines obtaining and enforcing patents in Ukraine, in particular the legal landscape and recent developments in patent protection at the customs border, obtaining patent protection, patent enforcement including patent licensing strategies, enforcement and defence in the courts and evidence collection for patent enforcement, including general issues and peculiarities for patent infringement proceedings. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter explains the application of the Product Liability Directive in the case of off-label use of medicinal products. In particular, it considers the concept of off-label use, including its background and place in clinical practice, the Product Liability Directive and its main provisions, the liability of the producer under the Product Liability Directive in the case of off-label use, and the liability of the prescribing physician and the pharmacist. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article examines notification of research, development and innovation (R&D&I) aid and exemptions, examination of notified state aid and research, technology transfer and prohibited state aid. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Important reforms to the litigation funding regime in England and Wales came into force on 1 April 2013. The claimant lawyer bar has warned that the reforms are likely to seriously impact on the viability of group product liability claims in future, due to the reduction in financial incentive for claimant lawyers to pursue such claims. This article looks at whether this is likely to be the case, or whether the various changes will mean that defendants are in fact more likely to face group claims in the future. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This Wiley Rein LLP memorandum discusses a Pennsylvania District Court's decision in Steinberg v. CVS Caremark Corp., which recognizes both the benefits of the uses and disclosures of de-identified health care information and the primacy of the HIPAA regulatory structure for defining the appropriate rules for this information.

This Dechert LLP memorandum discusses a recent inquiry by the US Senate Finance Committee alleging that the nation’s three largest home health companies, Amedisys, Inc., LHC Group, Inc. and Gentiva Health Services, Inc. were more focused on maximizing their reimbursement under the Medicare payment system than on the medical requirements of patients.

This Ropes & Gray LLP memorandum highlights the differences between the final rule from the Centers for Medicare & Medicaid Services (CMS) establishing Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program and the proposed rule the CMS released in April 2011.

This Dechert LLP memorandum discusses a joint policy statement from the Federal Trade Commission and Department of Justice providing antitrust guidance to those considering forming Accountable Care Organizations (ACOs) and posits four lessons that can be learned from the release of this guidance.

This article sets out the background to the European Commission's proposed new regulation to protect individuals relating to the processing of personal data and the free movement of such data, in relation to clinical trials (including data controllers and data processors and international transfers of clinical data), pharmacovigilance, health data and consent and medical research. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter provides an overview of the challenges facing the pharmaceutical industry in Brazil, including the regulatory framework for generics, similars and biosimilars, the exponential growth of the market, the problems still existing in the competition with non-interchangeable copies (similars) and the absence of compliance with international standards, to date. The Brazilian government policies to favour domestic pharmaceutical industries and the country's lack of clear rules regarding the purchasing preferences, with its recently enacted government purchasing programme, are also covered. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter analyses the provisions of the South Korea-US Free Trade Agreement (FTA), which was signed by South Korea and the US on 30 June 2007 and will take effect on 15 March 2012. It looks at the FTA in terms of the adoption of the independent review process in the pharmaceutical sector, the introduction of the approval-patent linkage system, data exclusivity, customs duties and non-tariff barriers and competition law. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article illustrates how a complex and evolving legal and regulatory environment gives rise to unique challenges for those engaged in European M&A in the life sciences sector, by analysing a hypothetical M&A. In particular, it examines: • A life sciences M&A case study. • Due diligence and its impact. • Intellectual property issues. • Structuring the deal. • European competition laws. • Anti-corruption laws. • Employment issues. • Tax issues. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article explores some of the problematic aspects of CMS' proposals to regulate the MDRP, including its questionable exercise of delegated authority. In particular, it examines historical regulation of AMP, expansion of the Medicaid drug rebate programme, determining indirect sales to retail community pharmacies, calculating AMP for 5i drugs, Best Price, new requirements for line extensions, treatment of coupons, vouchers and co-payment assistance, new definition of wholesaler and the authorised generic rule on AMP and changes to CMS' policy on restatements of AMP and Best Price. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Parallel trade in the European pharmaceutical sector is widespread. To deal with parallel trade, pharmaceutical companies operating in the EU usually respond by adopting dual pricing schemes and allocation systems. To a certain extent, such schemes and systems are supported by European pharmaceuticals regulation. Behaviour such as dual pricing schemes and supply allocation systems have been the subject of legal dispute for some years. Another issue that continues to be the subject of legal dispute concerns the repackaging of pharmaceuticals that have been parallel imported. This chapter considers recent case law on these issues and summarises any conclusions that can be drawn. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter describes the extent of anti-trust enforcement in the context of patent settlement agreements in the EU and US, sets out the current positions of the anti-trust authorities and any legislative initiatives taken in this area, and documents significant pending competition investigations or litigation in the EU and US. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article looks at patent regulation in Ukraine, focusing on: The regulatory framework. Patent protection and enforcement. Enforcement and defence of patent rights in Ukrainian courts. Patent infringement on the internet. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article includes: A general overview of SPCs. A summary of key recent case law from the EU Court of Justice (ECJ) on the conditions for obtaining an SPC. Negative term SPCs and paediatric extensions. An analysis of marketing authorisation in the context of SPCs. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Various reforms have been proposed to the litigation funding regime in England and Wales. This article examines the nature of the reforms and other proposals, conditional fee agreements, after the event insurance, damages based agreements, third party funding/litigation funding, qualified one-way cost shifting, liberalisation of the legal market and the impact on pharmaceutical claims. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Under European pharmaceutical law innovator pharmaceutical companies are granted a period of regulatory data exclusivity in which a generic applicant cannot refer to the innovator's data to obtain a marketing authorisation. The European legislation was amended in 2004 and currently contains a period of eight plus two (plus one) years of regulatory data protection (RDP). This article sets out a brief description of RDP under European law, the main changes to the legal system introduced in 2004 and an update of recent developments regarding the interpretation of European RDP law. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter looks at recent developments in Canadian public policy and case law that directly or indirectly affect biotechnology. It summarises the 2009 Canadian federal budget and a number of recommendations for improving government programmes, including the 2010 report, "An Action Plan For Prosperity", published by the Coalition for Action on Innovation in Canada. It then outlines the key issues and challenges for the Canadian government to improve business R&D spending, rates of commercialisation and productivity growth. Finally, this chapter looks at the functions of the Patented Medicine Prices Review Board (PMPRB) and recent litigation trends (including class actions). This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This Dechert LLP memorandum discusses an FTC study on the competitive impact of authorized generics, providing strong support for the conclusion that entry by authorized generics is procompetitive because it lowers prescription drug prices without deterring generic entry.

This Ropes & Gray LLP memorandum discusses a final rule from the US Department of Health and Human Services amending the Public Health Service (PHS) regulations on the disclosure of the financial conflicts of interest by research institutions and investigators that seek or receive PHS funding. The final rule reflects HSS' efforts to strengthen transparency and oversight in the face of increasing numbers of, and complexity in, financial relationships between biomedical researchers and industry.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses a long-awaited report from the Committe on the Public Health Effectiveness of the Institute of Medicine on the FDA 510(k) Clearance Process, recommending a complete overhaul of the 510(k) process.

This Ropes & Gray LLP memorandum discusses an Advanced Notice of Proposed Rulemaking (ANPRM) from the US Department of Health and Human Services (HHS) describing comprehensive potential revisions to the Common Rule, which represents a common set of requirements for human subjects protection in research funded by fifteen federal agencies.

This Ropes & Gray LLP memorandum discusses draft guidance from the Food and Drug Administration (FDA) describing how it intends to apply its regulatory authority to certain software applications intended for use on mobile platforms, which the agency terms "mobile medical applications" or "mobile medical apps."

This Ropes & Gray LLP memorandum discusses an updated report released by Massachusetts Attorney General Martha Coakley on health care cost trends and cost drivers that includes new recommendations designed to encourage consumers to make value-based purchasing decisions and providers to improve care coordination.

This Ropes & Gray LLP memorandum discusses the Supreme Court's decision in Sorrell v. IMS Health Inc., which held that a Vermont statute that prohibits pharmaceutical manufacturers from obtaining or using "prescriber-identifiable information" collected from pharmacists for the purposes of "marketing or promoting a prescription drug - is a "speaker- and content-based burden on protected expression" that cannot survive "heightened judicial scrutiny."

This Ropes & Gray LLP memorandum discusses the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), which granted broader rights to individuals with respect to their Protected Health Information (PHI), including expanding the rights of individuals to receive and accounting of certain disclosures made through an electronic health record (EHR), but has limited the time period for maintaining documentation of such disclosures to the three years prior to the date on which the accounting is requested.

This Ropes & Gray LLP memorandum discusses the final rule from the Centers for Medicare & Medicaid Services (CMS) to implement a hospital value-based purchasing (VBP) program. The VBP program is designed to reward hospitals that score well on certain quality care measures with higher payments, as mandated by the Affordable Care Act (ACA) of 2010.

This Ropes & Gray LLP memorandum discusses a proposed rule from the Centers for Medicare & Medicaid Services (CMS) to implement a hospital value-based purchasing (VBP) program as mandated by the Affordable Care Act (ACA) that would apply to payments for discharges occurring on or after October 1, 2012, and would reward with higher payments hospitals that score well on quality care measures.

Some are pessimistic about the UK public markets' ability to finance emerging life sciences companies. This chapter considers whether this view is fair, and the range of financing structures available. The statistical data was taken as at 31 December 2010. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article looks at important considerations and global developments in biosimilar regulation, including scientific and regulatory challenges, patent considerations in the US and considerations for the industry as a whole. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A drug or device recall can have enormous impact on a drug or medical device company, and on the future of the concerned product. Careful planning can help to mitigate the risks of a recall and contain liability, while allowing the company to respond quickly to a crisis. This article traces, from a drug and device company's perspective, the steps of a product recall through its various stages as they impact on potential liability and litigation. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Traditionally, the market entry of a generic pharmaceutical brings about a 30% to 40% shift in market share from the innovative pharmaceutical company to the generic firm, along with a 20% (in the first year after generic entry) to 25% (in the second year after generic entry) reduction in the average medicine price. With patent term expiries fully underway, innovative market players increasingly have recourse to a toolbox of strategies. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article looks at the challenges facing the German medical care system and looks at past and future reforms in the German pharmaceutical market, focusing on: • The Act for the restructuring of the drug market (Gesetz zur Neuordnung des Arzneimittelmarktes) (AMNOG). • The early benefit assessment. • The reference price system. • Negotiations between pharmaceutical companies and the statutory health insurance (Gesetzliche Krankenversicherung) (SHI). • Manufacturer's statutory rebates for pharmaceuticals. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article sets out some of the main features of EU Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals) (REACH) and how it is likely to affect medical device companies. It also provides an overview of the most significant EU regulatory developments as they apply to the medical devices industry sector. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article examines the following two significant recent changes to the regulatory regime in Japan relating to the business of originator pharmaceutical companies and generic pharmaceutical companies: • The extension of the study period for drugs with new active ingredients. • The new permissibility of partial applications and approvals. These changes directly impact certain legal protections (such as the re-examination system and patent term extensions) in Japan for pharmaceutical companies that produce original drugs. These protections are increasingly important in the light of governmental steps to increase the historically low market share of generic drugs in Japan. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

In the past 18 months, there have been significant anti-corruption developments for companies and individuals, particularly in the healthcare sector. Against this background, this chapter looks at recent developments in enforcement of anti-corruption laws. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This chapter reviews the current regulatory framework concerning risk management of medicinal products in the EU and the US. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Pharmaceutical regulatory law and patent law are often seen as separate legal fields governed by distinct laws. However, these fields can be seen to interact in Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). In recent years a number of cases have emerged under the framework of the SPC Regulation, in which the interpretation of certain provisions has led to a discussion of various concepts that have been introduced from patent law or regulatory law. Another, more recent regulatory development that has created an additional interaction between regulatory law and the SPC Regulation is Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Regulation). The Paediatric Regulation couples the obligation to conduct paediatric clinical research with an extension of an SPC. This means that an additional regulatory factor has been introduced that influences SPCs. This article looks at the: • Legal framework. • Interaction between pharmaceutical regulatory law, patent law and the SPC and the Paediatric Regulation in case law in Europe. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Groom Law Group, Chartered Memorandum discussing the interim guidance released by the Department of Labor, Department of Health and Human Services and Treasury Department, which establishes an enforcement grace period for key aspects of the new claims and appeal procedure rules under the Patient Protection and Affordable Care Act (PPACA), as amended (also referred to as the Affordable Care Act (ACA)). This Memorandum also discusses recently released ACA FAQs and Internal Revenue Service Notice 2010-63 related to applying nondiscrimination rules to insured group health plans. Click here to view full text.

Groom Law Group, Chartered Memorandum describing the Pre-Existing Condition Insurance Plan program created by the Patient Protection and Affordable Care Act to provide health insurance coverage to uninsured individuals with pre-existing conditions. Click here to view the full text.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses two preliminary reports released by the Center for Devices and Radiological Health of the Food and Drug Administration (FDA) making recommendations addressing the FDA's regulation of medical devices.

This Ropes & Gray LLP memorandum discusses a proposed rule issued by the Center for Medicare and Medicaid Services (CMS) that would affect Medicare Part B coverage for drugs and biologics by specifying that payment under Medicare is unavailable for the portion of a drug or biologic in a container or vial that exceeds the amount specified on the product’s approved label.

Seyfarth Shaw LLP Memorandum describing the rules relating to claims and appeals procedures applicable to group health plans and group and individual health insurance issuers. Click here to view full text.

This Dechert LLP memorandum discusses a rule proposal by the Department of Health and Human Services (DHHS) to modify the privacy, security and enforcement rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Groom Law Group, Chartered Memorandum describing the interim final rules relating to internal claims and appeals and external review processes under the health care reform legislation. Click here to view the full text.

This Ropes & Gray memorandum discusses the release of a final rule by the Center for Medicare and Medicaid Services (CMS) setting forth the requirements providers must satisfy to become meaningful users of "certified" electronic health record (EHR) technology. It also discusses a companion final rule issued by the Office of the National Coordinator for Health Information Technology (ONC) on the same day.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the issuance of a notice of proposed rulemaking strengthening and expanding the privacy and security obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Groom Law Group, Chartered Memorandum explaining the interim final rules under the health care reform legislation requiring group health plans and health insurers to cover specified preventive health services and to eliminate cost-sharing requirements for these services. Click here to view full text.

This Ropes & Gray LLP memorandum discusses the changes made to federal Stark Law through the Center for Medicare and Medicaid Services' (CMS) implementation of the Patient Protection and Affordable Care Act, including enhanced disclosure requirements under the in-office ancillary services exception and the whole-hospital exception.

This Ropes & Gray LLP memorandum discusses a report released by the Association of American Medical Colleges on financial relationships and their impact on clinical care entitled "In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making."

Seyfarth Shaw LLP Memorandum highlighting the changes that both grandfathered and non-grandfathered health plans will need to consider for plan years beginning on or after September 23, 2010. Click here for full text.

Groom Law Group, Chartered Memorandum explaining the requirements related to pre-existing condition exclusions, annual and lifetime dollar limits, rescissions, choice of providers and coverage of emergency services under the health care reform legislation and the interim final rules issued by government agencies. Click here to view full text.

This Ropes & Gray LLP memorandum discusses interim final rules for group health plans and health insurance coverage on certain patient protections under the Patient Protection and Affordable Care Act (PPACA) as released by the US Departments of Treasury, Labor, and Health and Human Services.

This Ropes & Gray LLP memorandum discusses interim final rules for group health plans and health insurance coverage on grandfathered health plan status under the Patient Protection and Affordable Care Act (PPACA) as released by the US Departments of Treasury, Labor and Health and Human Services.

This Ropes & Gray LLP memorandum discusses the Supreme Court's decision to hear the case of Matrixx Initiatives, Inc. v. Siracusano, which addresses a stockholder's claim that a pharmaceutical company improperly failed to disclose adverse drug reactions even though the events were not statistically significant.

This Ropes & Gray LLP memorandum discusses the Supreme Court's grant of certiori to Mayo Foundation for Medical Education & Research v. United States, which will decide whether the Treasury Department can categorically exclude all medical residents and other full-time employees from the federal law that exempts work performed by "students" from the obligation to pay Social Security taxes.

This Ropes & Gray LLP memorandum discusses proposed revisions from the Department of Health and Human Services (HHS) to the rules regarding the identification and management of financial conflicts of interest that apply to institutions that seek or receive Public Health Service (PHS) funding for research.

This Ropes & Gray LLP memorandum discusses S. 2437 of the Massachusetts Senate, which contains a number of provisions primarily intended to increase the authority of the Division of Insurance (DOI) over insurance companies offering products in Massachusetts small group and individual health insurance markets.

This Ropes & Gray LLP memorandum discusses the implementation of the Patient Protection and Affordable Care Act (PPACA) and a package of related amendments under the Health Care and Education Reconciliation Act.

This Ropes & Gray LLP memorandum discusses the Southern District of New York's decision in Association for Molecular Pathology v. United States Patent and Trademark Office (Myriad), which could significantly impact the patentability of certain types of patent claims in biotechnology.

This Ropes & Gray LLP memorandum discusses the authorization under Congressional health care reform of the Food and Drug Administration (FDA) to approve biological products through an abbreviated regulatory pathway that does not require these products to undergo full clinical testing.

This Ropes & Gray LLP memorandum discusses the passage of the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Reconciliation Act and its effect on the pharmaceutical, biotechnology and medical device industries.

This Ropes & Gray LLP memorandum discusses the "Sunshine Provisions" of the Patient Protection and Affordable Health Care Act (PPACA), which require pharmaceutical, medical device, biological and medical supply manufacturers to begin reporting to the federal government the payments they make to physicians and teaching hospitals.

This Ropes & Gray LLP memorandum discusses the Patient Protection and Affordable Care Act (PPACA) and the four new requirements it imposes on non-profit hospitals for them to retain their tax-exempt status.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the most sweeping changes to the US health care system since the creation of Medicare and Medicaid, increasing the regulation and oversight of health insurance plans.

This Ropes & Gray LLP memorandum discusses the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Reconciliation Act and the way these pieces of legislation add, increase and expand important taxes.

This Ropes & Gray LLP memorandum discusses the passage of the Patient Protection and Affordable Care Act (PPACA) by the House of Representatives and the House's approval of the Health Care and Education Reconciliation Act, which is a package of changes to the Senate-approved health bill.

This Ropes & Gray LLP memorandum discusses a final notice from the Health Resources and Services Administration (HRSA) that allows covered entities participating in the 340B Drug Pricing Program to contract with multiple contract pharmacies to provide discounted drugs.

This Ropes & Gray LLP memorandum discusses a lawsuit by the Connecticut Attorney General under the Health Information Technology for Economic and Clinical Health (HITECH) Act to enforce the privacy and security provisions of the Health Information Portability and Accountability Act (HIPAA).

This Dechert LLP memorandum discusses the publication of rules relating to electronic health record (EHR) technology and its "meaningful use" for purposes of receiving Medicare and Medicaid incentive payments.

This Ropes & Gray LLP memorandum discusses regulation from the Center for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), relating to how health care providers can demonstrate "meaningful use" of electronic health record (EHR) technology in order to qualify for incentive payments and avoid penalties under the American Recovery and Reinvestment Act of 2009.

This Ropes & Gray LLP memorandum discusses the passage of the Patient Protection and Affordable Care Act (PPACA) and compares the Senate version with the version passed in the House of Representatives.

Many life science companies rely on their employees' inventiveness to fuel their R&D and generate patents. Employees who create patentable inventions may be entitled to compensation. However, the laws in this area vary significantly across European jurisdictions. A number of substantial compensation awards have been made recently. This chapter considers the legal framework for compensating employees for patented inventions in the UK, France, Germany, The Netherlands and Belgium, whether an employee's rights to compensation can be altered contractually, and provides a checklist of considerations for those considering bringing or defending claims. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

The Australian pharmaceutical market is both highly competitive and highly regulated. There are many legal issues which a pharmaceutical company conducting business in Australia must contend with. This article examines general principles governing interlocutory relief, the impact of the Government pharmaceutical pricing regime, recent case law on interlocutory injunctions, and whether there is a trend in the granting of pharmaceutical interlocutory injunctions. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article sets out some of the main features of the EU REACH Regulation and how it might affect medical device companies. In particular, the requirement to register, the substance information exchange forum (SIEF), the consortium and data sharing, supply chain interaction and obligations of various members, and commercial relationships affected by REACH. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article examines UK regulation of individual patient supply, importing unlicensed products, and the current status of the UK Medicines and Healthcare product Regulatory Agency (MHRA) consultation. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This chapter considers: the global trends in pharmaceutical crime; various policy-related initiatives that are being advanced to fight pharmaceutical crime; the responses of policymakers at the multinational, national and industry level to the particular problems raised by the internet; and new technologies which may assist in tackling pharmaceutical crime. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

The life sciences industry has experienced major changes over the last few years, and will continue to be affected by a number of technological, commercial and legal developments in the coming years. This article examines the changes that have occurred in the key life sciences jurisdictions of Europe, the US and China, and considers lawyers' predictions for the future of these local and international markets. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses recent settlements and enforcement actions and analyzes trends in the risk areas and the evolving legal theories underlying how clinical studies are disclosed to health care professionals and the public. It also discusses the relationships between investigators/study authors and manufacturers, company-sponsored coverage and reimbursement support activities and types of liability.

Stakeholders in the life sciences industry are witnessing an increasing number of initiatives in the UK and across Europe to facilitate collective legal actions. There are a growing number of private sector entrants to the collective actions and third-party funding marketplace. The impact may increase the litigation risk in Europe, although it is important that this risk is not overstated. This article surveys key developments in collective actions and third-party funding at a European level and in a number of key European jurisdictions. It also discusses specific risks for the life sciences industry.

Effective life cycle management is crucial for pharmaceutical companies, yet it can be difficult. The challenge is to find ways of achieving the right balance between adequate protection of the interests of those who invest substantial sums of money in research, and the need to make medicines available to patients at a fair price. This article examines non-patent legal issues, including regulation and anti-trust, and patent issues, including the use of patents, obtaining patents and SPCs, enforcement and preliminary injunctions. The article also looks at India as an example of how patent issues affect life cycle management in the broader global context.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses guidance released by the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) describing its approach to excluding individuals from participation in federal health care programs for controlling a sanctioned entity.

This Epstein Becker & Green, P.C. memorandum discusses an Executive Order requiring state agencies to issue regulations imposing caps on executive compensation and administrative costs on for-profit and not-for-profit service providers that receive State-authorized financial assistance or payments. New York's Governor, Andrew M. Cuomo, executed the Order on January 18, 2012, to prevent public funds from being diverted to excessive compensation and unnecessary administrative costs. The new limitations imposed by the Executive Order may adversely affect hospitals and other service providers especially Medicaid-managed healthcare plans.

A new edition of the Life Sciences multi-jurisdictional guide, which deals with cross-border issues and answers questions on life sciences law from the perspective of practitioners in key jurisdictions worldwide.

PLC Cross-border has published a new edition of the Life Sciences multi-jurisdictional guide, which deals with cross-border issues and answers key questions on life sciences law from the perspective of practitioners in key jurisdictions worldwide.

A new edition of the Life Sciences multi-jurisdictional guide, which deals with cross-border issues and answers questions on life sciences law from the perspective of practitioners in key jurisdictions worldwide.

A new edition of the Life Sciences multi-jurisdictional guide, which deals with cross-border issues and answers questions on life sciences law from the perspective of practitioners in key jurisdictions worldwide.

A Q&A guide to medicinal product regulation and product liability law in the Czech Republic. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in the Czech Republic: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in the Czech Republic. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in the Czech Republic: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in China. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in China: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in India. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in India: overview. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Ireland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Ireland: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Portugal. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Portugal: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Singapore. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Singapore: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Spain. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Spain: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in UK (England and Wales). The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in the UK (England and Wales): overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in the United States. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in the United States: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in China. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in China: overview. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in India. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in India: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Ireland. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Ireland: overview. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Portugal. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Spain. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Spain: overview. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in UK (England and Wales) . The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in the UK (England and Wales): overview. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in the United States. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in the United States: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Australia. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Australia: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Finland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Finland: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Germany. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Germany: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. This Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in South Africa. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in South Africa: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Australia. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Australia: overview. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Finland. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Finland: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Germany. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Germany: overview. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in South Africa. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in South Africa: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Brazil. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Brazil: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Japan. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Japan: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Mexico. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Mexico: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in South Korea. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in South Korea: overview. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Sweden. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Sweden: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Thailand. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Thailand: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in The Netherlands. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in The Netherlands: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to medicinal product regulation and product liability law in Vietnam. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Vietnam: overview. To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Brazil . The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Brazil: overview. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Japan. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Japan: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Mexico. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Mexico: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Singapore. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Singapore: overview. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in South Korea. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in South Korea: overview. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences Law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Sweden. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Sweden: overview. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Thailand. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Thailand: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in The Netherlands. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in The Netherlands: overview. The Q&A is part of the Multi-jurisdictional Guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to pharmaceutical IP and competition law in Vietnam. The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Vietnam: overview. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Romania. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in France. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Hungary. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Italy. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Switzerland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Turkey. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Denmark. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Argentina. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Austria. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Belgium. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Canada. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Greece. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences in Norway. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Poland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in the Ukraine. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in the Russian Federation. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.